1. Field of the Invention
The present invention relates generally to implants and methods for the treatment of pelvic organ prolapse conditions, and in particular for the treatment of vaginal prolapse conditions.
2. Background Discussion
Generally speaking, pelvic organ prolapse occurs when organs or structures within the pelvic cavity prolapse, or descend from their normal anatomical positions. These conditions can include the rectum descending into the back wall of the vagina to create a bulge that may affect bowel function (rectocele), herniation of the small bowel (enterocele), the uterus descending into the normal vaginal space (uterine prolapse), the bladder descending into the vagina typically as a result of a prolapse of the front wall of the vagina (cystocele), or even the vagina descending into the vaginal cavity itself (vaginal vault prolapse). Pelvic organ prolapse occurs as a result of weakening or damage to the muscles and tissues that support the vagina and surrounding organs that otherwise function to hold them in place, often due to the trauma of childbirth, loss of estrogen after menopause, or following a hysterectomy where removal of the uterus affects the normal structures holding the top of the vagina in place.
Various surgical treatments are available depending on the type and severity of the prolapse, most of which involve utilizing implantable meshes or other structures to help provide support to prolapsed organs, or various suspension techniques in which the surgeon attempts to reposition the prolapsed organ and secure or attach it to stronger, intact tissue in the pelvic cavity or to bone or periosteum.
For vaginal vault prolapse, the anatomical defect typically is in or around the upper portion of the vagina, and treatment involves reattachment of this portion of the vagina to stronger tissue or to the sacrum to thereby re-suspend the vagina in its normal anatomical position.
One known procedure for addressing vaginal vault prolapse utilizes a “Y-mesh” such as the ALYTE® Y-Mesh Graft sold by C.R. Bard, Inc. of Covington, Ga. The mesh includes first and second vaginal mesh flaps, and a sacral flap extending in the opposite direction from the vaginal mesh flaps. The two vaginal mesh flaps are positioned and secured on opposite surfaces, anterior and posterior, on the upper portion of the vagina. The vagina is then elevated into the proper position, and the sacral flap is attached to the sacral promontory, thereby suspending the vagina in its normal anatomical position.
The Y-mesh described above is comprised of the same mesh structure throughout, however the vaginal mesh flaps are extended with each end sewn together to form a single, double density sacral flap. Vaginal tissue to which the vaginal mesh flaps are secured, however, is very compliant tissue and ideally, the compliance of the mesh should mimic that of the natural tissue. The sacral flap should have a reasonable degree of stiffness in the longitudinal direction, as suspension of the vagina from the sacrum is via the sacral flap.
Although compliance of the vaginal flaps is important following implantation, it is also desirable that the implant have a reasonable degree of compliance prior to and during implantation to facilitate handling by the surgeon. Further, in known procedures, while the surgeon is attaching the first vaginal flap, the second vaginal flap is prone to interfere (both physical interference and visual obstruction), and typically requires the surgeon to temporarily restrain the second vaginal flap while securing the first vaginal flap.
An improved Y-mesh type implant having improved compliance properties and features would be highly desirable.